Study on Effects of BMS-955176 on the Pharmacokinetics of Probe Substrates
Phase 1
Completed
- Conditions
- HIV Infections
- Interventions
- Drug: CYP and transporter probe substrates
- Registration Number
- NCT02578277
- Lead Sponsor
- ViiV Healthcare
- Brief Summary
The purpose of the study is to study the effects of BMS-955176 on the single-dose PK parameters of probe substrates caffeine, metoprolol, montelukast, flurbiprofen, omeprazole, midazolam, digoxin, and pravastatin
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 59
Inclusion Criteria
- Written Informed Consent
- Healthy male and female (not of childbearing potential) subjects as determined by medical history, surgical history, physical examination, vital signs, ECGs, and clinical laboratory determinations
- Body mass index (BMI) of 18.0 kg/m2 to 32.0 kg/m2, inclusive, at screening and Day 1. BMI = weight (kg)/[height(m)]
- Women must have documented proof that they are not of childbearing potential (eg, surgically sterile, postmenopausal with a documented follicle-stimulating hormone (FSH) > 40 mIU/mL) and should not be breast feeding
- Males who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception for the duration of treatment with BMS-955176 in addition to a post-treatment completion period
Exclusion Criteria
- Any significant acute or chronic medical illness
- Use of tobacco, excessive alcohol
- Medical history indicative of an increased risk of a cardiac arrhythmia or cardiac disease and history of asthma, bronchospasm, sleep apnea, rhabdomyolysis, a bleeding disorder, a major depressive disorder within the past 6 months, peptic ulcer or significant GI bleed, Raynaud's disease, or any gastrointestinal surgery that could impact upon the absorption of study drug
- Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECG, or clinical laboratory determinations beyond what is consistent with the target population
- History of allergy to BMS-955176, digoxin (or any member of the digitalis glycosides class of drugs), caffeine, metoprolol, montelukast, flurbiprofen, omeprazole, midazolam, or pravastatin, or to any related compounds
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Single sequence, 3-period DDI (drug-drug interaction) BMS-955176 plus CYP and transporter probe substrates Single sequence Single sequence, 3-period DDI (drug-drug interaction) CYP and transporter probe substrates Single sequence Single sequence, 3-period DDI (drug-drug interaction) BMS-955176 Single sequence
- Primary Outcome Measures
Name Time Method Cmax (maximum observed concentration) Days 1 to 18 AUC(0-T), area under the concentration-time curve from time zero to the time of the last quantifiable concentration Days 1 to 18 AUC(INF), area under the concentration-time curve from time zero extrapolated to infinite time Days 1 to 18
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
GSK Investigational Site
🇺🇸Austin, Texas, United States